Senior QA Manager – Facilities & Compliance

Quva-Pharma; Bloomsbury (NJ); On-site; USD 114,000 - 156,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement plan

Paid time off

Career growth opportunities

Competitive salary based on experience

Job summary

Quva is seeking a Manager, Quality Assurance – Facilities Maintenance for its Bloomsbury, NJ site to lead QA oversight of facility maintenance and engineering projects, repairs, and work orders, ensuring compliance with cGMP and FDA regulations. The role documents activities and upholds high quality standards to safeguard patient care.

You will supervise QA staff, review work orders, enforce cleanroom standards, and drive CAPA actions, while collaborating across departments to maintain site-wide

Qualifications

• Bachelor’s Degree in Life Science or related field.
• 3+ years’ supervisory or management experience.
• 5+ years’ experience in Quality Assurance / cGMP / FDA regulated industry.
• Understanding of Good Documentation Practices.
• Experience with Maintenance Safety practices and protocols.
• Knowledgeable in ISO 5/7 environment cleanroom gowning.
• Knowledge of manufacturing processes, procedures and basic facilities maintenance functions.
• Able to lift up to 50 lbs. during shift.
• Authorized to work in the United States; no visa sponsorship.

Responsibilities

• Manages Quality Assurance – Facility / Maintenance staff.
• Reviews and approves all facility related work orders for the site.
• Ensures compliance with clean room standards during projects.
• Oversees investigations of failures and deviations.
• Develops corrective and preventive actions.
• Monitors environmental monitoring data for facilities/maintenance.
• Maintains QA records for facilities/maintenance.
• Maintains testing equipment records (calibration/certification).
• Assists in developing QA policies and procedures for facilities.
• Communicates discrepancies to appropriate departments.
• Enforces applicable personnel policies and procedures.

Skills

Life Science

Supervisory experience

Quality Assurance

cGMP knowledge

Documentation practices

Regulatory compliance

Communication skills

Environmental monitoring

Education

Bachelor’s Degree in Life Science or related field

Job description

Quva is seeking a Manager, Quality Assurance – Facilities Maintenance for its Bloomsbury, NJ site to lead QA oversight of facility maintenance and engineering projects, repairs, and work orders, ensuring compliance with cGMP and FDA regulations. The role documents activities and upholds high quality standards to safeguard patient care.

You will supervise QA staff, review work orders, enforce cleanroom standards, and drive CAPA actions, while collaborating across departments to maintain site-wide